Baxalta is a global biopharmaceutical company focused on developing therapies for orphan diseases and underserved conditions in hematology, immunology and oncology. It has a broad pipeline of 20 new product launches expected by 2020, with 10 regulatory approvals received in the past six months. Baxalta employs 17,000 people worldwide and generated over $6 billion in sales in 2015, with double-digit sales growth across its portfolio of therapies for rare bleeding disorders, immunodeficiencies, and cancers.
The importance of getting a Biotechnology launch right the first time and the difficulty of recovering from a slow sales trajectory suggest that there is a need to evolve the go-to-market approach to ensure launch success. Successfully bringing a product to market has been increasingly difficult as the U.S. Healthcare Market has evolved since implementation of the Affordable Care Act. Pricing has become more controlled - and value based - as healthcare costs have increased to an unsustainable level. Customers realize there is little product differentiation and the traditional Field Sales representative based go-to-market models are struggling to effectively communicate the value proposition to more demanding and informed customers and stakeholders. The results of our pre-launch survey are provided here along with recommendations for what Biotechnology companies can do to improve launch readiness.
Luis Cantarell, EVP of Zone EMENA, presentes to 2015 CAGE conference in LondonNestlé SA
Luis Cantarell, Executuive Vice-President in charge of Nestlé Zone Europe, Middle East and North Africa, presents to the 2015 CAGE (Consumer Anylsts' Group Europe) on 'Translating the Nestlé roadmap into executional excellence'.
SMi Group presents the 23rd annual industry leading summit on Pharmaceutical Pricing & Market Access, 11 – 12 Oct 2017, London, UK.
Pharmaceutical Pricing & Market Access 2017 will tackle industry challenges head on by preparing attendees to develop a successful market access strategy for the ever changing pharmaceutical and payer landscape. Join us this autumn for insight into how manufactures plan to limit further price increase; a progressive outlook into the future of pharmaceutical pricing & reimbursement (P&R); stakeholder collaboration; meaningful patient engagement opportunities; and discuss what can be done for the industry to achieve efficient reimbursement and for patients to gain access to affordable medication.
Highlights will include an exclusive opening keynote from the FDA and interactive training on Real World Evidence (RWE). Featured Speakers include: Lundbeck, FDA, Shire, Sobi, Teva, Grifols, Allergan, Sanofi and more!
Trends, recruitment and remuneration in the Healthcare & Life Sciences sectorMichael Page
This report arises out of Michael Page’s global experience in helping companies in the Healthcare & Life Sciences sector to recruit the best talents for business success. In most of the countries where we operate, the prevailing regulatory and pricing frameworks set by government heavily influence the market. Now that many patents have reached end of life, generic drugs have taken an important share from large pharmaceuticals, and have revolutionised the market in doing so. As a consequence, companies producing pharmaceuticals or medical devices are increasingly challenged to hone their profitability through innovation and R&D. Acquisitions, always a feature of the pharmaceutical industry, are on the increase. Many companies needing to expand their R&D capabilities have biotechnology firms in their sights.
Robert Kilmer, President, Nestlé Dreyer’s Ice Cream, Nestlé USA, om hte ice cream business of Nestlé USA for our 2014 investor seminar, Boston USA, June 3-4.
The importance of getting a Biotechnology launch right the first time and the difficulty of recovering from a slow sales trajectory suggest that there is a need to evolve the go-to-market approach to ensure launch success. Successfully bringing a product to market has been increasingly difficult as the U.S. Healthcare Market has evolved since implementation of the Affordable Care Act. Pricing has become more controlled - and value based - as healthcare costs have increased to an unsustainable level. Customers realize there is little product differentiation and the traditional Field Sales representative based go-to-market models are struggling to effectively communicate the value proposition to more demanding and informed customers and stakeholders. The results of our pre-launch survey are provided here along with recommendations for what Biotechnology companies can do to improve launch readiness.
Luis Cantarell, EVP of Zone EMENA, presentes to 2015 CAGE conference in LondonNestlé SA
Luis Cantarell, Executuive Vice-President in charge of Nestlé Zone Europe, Middle East and North Africa, presents to the 2015 CAGE (Consumer Anylsts' Group Europe) on 'Translating the Nestlé roadmap into executional excellence'.
SMi Group presents the 23rd annual industry leading summit on Pharmaceutical Pricing & Market Access, 11 – 12 Oct 2017, London, UK.
Pharmaceutical Pricing & Market Access 2017 will tackle industry challenges head on by preparing attendees to develop a successful market access strategy for the ever changing pharmaceutical and payer landscape. Join us this autumn for insight into how manufactures plan to limit further price increase; a progressive outlook into the future of pharmaceutical pricing & reimbursement (P&R); stakeholder collaboration; meaningful patient engagement opportunities; and discuss what can be done for the industry to achieve efficient reimbursement and for patients to gain access to affordable medication.
Highlights will include an exclusive opening keynote from the FDA and interactive training on Real World Evidence (RWE). Featured Speakers include: Lundbeck, FDA, Shire, Sobi, Teva, Grifols, Allergan, Sanofi and more!
Trends, recruitment and remuneration in the Healthcare & Life Sciences sectorMichael Page
This report arises out of Michael Page’s global experience in helping companies in the Healthcare & Life Sciences sector to recruit the best talents for business success. In most of the countries where we operate, the prevailing regulatory and pricing frameworks set by government heavily influence the market. Now that many patents have reached end of life, generic drugs have taken an important share from large pharmaceuticals, and have revolutionised the market in doing so. As a consequence, companies producing pharmaceuticals or medical devices are increasingly challenged to hone their profitability through innovation and R&D. Acquisitions, always a feature of the pharmaceutical industry, are on the increase. Many companies needing to expand their R&D capabilities have biotechnology firms in their sights.
Robert Kilmer, President, Nestlé Dreyer’s Ice Cream, Nestlé USA, om hte ice cream business of Nestlé USA for our 2014 investor seminar, Boston USA, June 3-4.
2. Baxalta Incorporated (NYSE: BXLT) is a global biopharmaceutical leader developing, manufacturing and commercializing therapies for
orphan diseases and underserved conditions in hematology, immunology and oncology. Driven by passion to make a meaningful impact
on patients’ lives, Baxalta’s broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms
such as gene therapy. Launched in 2015 following separation from Baxter International, Baxalta’s heritage in biopharmaceuticals spans
decades. Baxalta’s therapies are available in more than 100 countries and it has advanced biological manufacturing operations across
12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, with its
Global Innovation Center in Cambridge, Massachusetts, Baxalta employs 17,000 employees worldwide.
Cover: Victor, who lives with hemophilia, is part of the Baxalta Global Ambassador program.
Serving patients is our inspiration
and we are passionate about
improving lives.
3. we have expanded our leadership and advanced our portfolio with
the launch of ADYNOVATE, an enhanced treatment option for
the hemophilia A community that delivers bleed protection while
also providing dosing flexibility for patients around prophylactic
treatment. We also received FDA approval in the fourth quarter for
VONVENDI, the first and only recombinant treatment for adults
living with von Willebrand disease—the world’s most common
bleeding disorder. The treatment is the first major therapeutic
innovation for von Willebrand disease in more than a decade, and
an important addition to our broadening portfolio of differentiated
products to help address challenging bleeding disorders.
In immunology, transformative therapies like HYQVIA, for patients
with primary immunodeficiency (PI), are supporting our transition
to a patient-centered, personalized model. We launched HYQVIA
in 2014 and continue to see great results; we have expanded our
presence in the PI segment in the United States and in select
European countries, and initiated a Phase III study to expand its label
to address unmet needs for chronic inflammatory demyelinating
polyneuropathy (CIDP) patients.
TO OUR SHAREHOLDERS
In launching Baxalta, it was apparent
from the start that the driving force behind
the success of our company was our
employees and our patients:
Our teams who possess a tremendous passion for the patients
they serve; the scientists who go to great lengths to understand
the impact that diseases and therapies have on families and
communities; and the manufacturing teams who wake up every
day knowing that each vial has the potential to save a life.
We’ve made extraordinary progress, transforming a valuable
business into a focused leader in rare diseases operating from a
position of strength in many of our key markets. While our structure
as an independent company facilitated our transition, the culture
we have built will be the spark that will allow Baxalta to continue on
our path as a global biopharmaceutical leader advancing innovative
therapies that improve patients’ lives. This focus on purpose-driven
performance is reflected in our 2015 results.
Our Foundation is Strong
We are an orphan disease company driven to make a difference for
patientsbycreatingsustainablebusinessesinhematology,immunology
and oncology. I am very proud of the progress we have made in each
of these areas since becoming a stand-alone company.
In hematology, we have an incredible 60-year legacy of best-in-
class therapies and expertise, which has driven our pursuit of a
world free of bleeds for hemophilia patients. In the past six months,
We are also building a focused oncology business, staying true to
our core mission of addressing disease areas with limited treatment
options. In addition to extensive partnerships and collaborations in
oncology, in the third quarter of 2015 we acquired the ONCASPAR
portfolio from Sigma-Tau Finanziaria S.p.A. ONCASPAR is a
cornerstone treatment for acute lymphoblastic leukemia (ALL),
providing a curative therapy as part of a multi-agent regimen to
thousands of children affected by this disease. We are actively
advancing additional late-stage pipeline assets acquired as part
of the ONCASPAR portfolio, including calaspargase pegol, an
investigational pegylated asparaginase treatment for ALL.
*Growth is at constant currency and compares to 2014 pro forma sales;
1H 2015 includes pro forma adjustments
4. We are on a Unique Path
Building on these recent successes, we are committed to driving
sustainable growth across all three businesses. We drove double-
digit sales growth (at constant currency) for full-year 2015, and
with approximately 20 new product launches by 2020, we
expect to deliver value to both patients and shareholders. This
“20 by 2020” journey is well underway. We have received 10
key regulatory approvals with two new products currently under
regulatory review. We are leveraging promising science through
new external collaborations to build our immuno-oncology pipeline
with disruptive technologies that have the potential to redefine
care for a range of underserved cancers. We continue to broaden
our hemophilia pipeline with a particular emphasis on gene
therapy technology, which, based on the premise of direct factor
replacement, holds the promise of achieving a long-term therapeutic
solution for people with hemophilia. And we are leveraging our
global development, manufacturing and commercial capabilities
to work with partners on a pipeline of biosimilars that will make
leading biologics more accessible for patients.
of existing assets, and remain disciplined about how we prioritize
strategic investments. It also means we must continue efforts
towardgeographicexpansionandmarketdevelopment—particularly
in emerging markets—to expand access and improve standards
of care.
We are Positioned to Lead
Overall, we are in a strong position to deliver on our promise to
patients—bringing innovative therapies to market so that our
patients can make their diseases the smallest part of their lives.
Inspired by this promise, in 2015 we delivered outstanding results
that created value for all of our stakeholders, made significant
steps toward our product launch goals and advanced novel new
mechanisms and approaches for challenging conditions.
Innovating for patients and putting them at the center: these
concepts are not only at our core, they are essential for our financial
performance and long-term success. It takes time and commitment
to understand the unique needs of our patients. As we embark on
this next phase in Baxalta’s journey as a combined organization
with Shire, if our success has proven anything, it’s that when we
do what’s right for our patients, we’re doing what’s right for our
business and for our shareholders.
Ludwig Hantson, Ph.D.
President and CEO
Innovating for patients and putting them at the center: these concepts are not only
at our core, they are essential for our financial performance and long-term success.
20 NEW PRODUCT
LAUNCHESBY2020
We are also making significant efforts to enhance operational
excellence across the entire company. This means developing
launch excellence as a core competency and making certain that
all of our operations—from manufacturing to patient access—are
aligned and ready to maximize the potential of each therapy in the
pipeline. It means we must look for new ways to get the most out
2 | Baxalta
5. MESSAGE FROM THE CHAIRMAN
When we launched Baxalta in July 2015,
our mission was clear—to become one
of the leading global biopharmaceutical
companies dedicated to advancing
the lives of people affected by rare and
underserved conditions.
Since separating from Baxter International on July 1, 2015, we have
made significant progress in unlocking the promise made to our
patients, customers and shareholders. During our short time as an
independent company, we have become an attractive innovation
partner, employer and investment.
We knew we were building something of great value, with teams
committed to growing and driving innovation on behalf of our
patients. We never expected it to result in an offer at such an early
stage (as of this writing, we have a merger agreement in place),
but the pillars of what we created are enduring and critical to our
success, and we are committed to ensuring they live on.
Purpose-Driven Performance
Baxalta employees are inspired by a sense of purpose-driven
performance.Ourteamsareaccountabletoachieveourcommitments,
and we deliver on behalf of the patients who rely on us. We have
proven this by achieving our strategic and financial objectives
with disciplined execution, and established a solid foundation for
the future.
Sustainable Growth
Our patient focus compels us to remain strong as a company,
execute well and lead in our markets, so that we can continue to
do what we do best—serve our patients and innovate to make their
lives better in the future. Our pipeline, which includes promising
and potentially disruptive technologies, is the engine that will
drive sustainable growth. In 2015 alone, we achieved three major
product approvals, which is a tribute to our strong commitment
to launch excellence.
Leader in Orphan and Underserved Diseases
We are applying our expertise and deep understanding of the
patient experience to develop transformative therapies to treat
orphan diseases and underserved conditions in hematology,
immunology and oncology, our three global businesses. Our
highly targeted innovation strategy and cutting-edge science,
combined with strategic partnerships, come together to spark
discovery for patients with limited treatment options. Our Global
Innovation Center in Cambridge, Massachusetts, which opened
in December, will further enable us to pioneer breakthroughs for
patients with unmet needs.
Thank you for joining us on this exciting journey that will allow us to
continue fulfilling our mission. I am confident that our team, along
with our new colleagues at Shire, will work to combine the best of
both organizations and foster a new, shared culture that has the
resources, the passion and the commitment to continue to make a
meaningful difference in the lives of our patients and their families.
Wayne T. Hockmeyer, Ph.D.
Chairman of the Board
2015 Annual Report | 3
6. Creating
opportunities
for joy
Just before her fourth birthday, Taylor was diagnosed with acute
lymphoblastic leukemia (ALL), which required her to be hospitalized
for 250 days over the following three years. Her diagnosis also made it
impossible for her to participate in sports and other physical activities
she loved. But even at that age, Taylor was determined—with equal
enthusiasm she turned to the arts and discovered new talents. She found
joy in drawing, painting, singing and playing instruments.
Today, Taylor has been cancer-free for more than a decade and devotes
much of her time to cancer-related charities and retreats. Having defeated
her illness, Taylor looks forward to an unhindered, music- and art-filled
life ahead.
Our promise. Her passion.
4 | Baxalta
9. Inspiring big dreams
Gabe was diagnosed with hemophilia not long after he was born. But that
has never stopped him from pursuing his dreams. When one door would
close, he would just open another. So, for instance, after being kneed in
the thigh during a basketball game that put him out of commission for
three months, he proved his resilience by taking up swimming.
In fact, his passion for swimming not only helped him to control his weight
and bleeds, but to develop a vigilance about his well-being overall that’s
made him an even better athlete and student. Today he’s the top student in
his biology class and an elite swimmer on his team. Smart and ambitious,
Gabe hopes to become an ER physician someday.
Our promise. His future.
2015 Annual Report | 7
10. Enabling imagination
to take flight
Tasheka spent nearly 40 years of her life undiagnosed for primary
immunodeficiency. She never knew why she was suffering from severe
ear, nose and throat infections and bronchitis up to 10 times a year, missing
over 40 days of work due to illness in one year alone.
Since she was diagnosed and began treating her condition, Tasheka has
cut work absences in half and is able to focus on what she loves most:
reading. Not surprisingly, she never goes anywhere without her Kindle.
Tasheka can now dream of salsa dancing and singing, international travel
and, someday, marriage. With her new diagnosis and treatment regimen,
she feels more optimistic about her future than ever before.
Our promise. Her determination.
8 | Baxalta
12. 2015 SALES BY PRODUCT CATEGORY* 2015 SALES BY GEOGRAPHY*
LEADERSHIP CAPABILITIES VALUE
DRIVING SUSTAINABLE GROWTH AND VALUE
$6 BILLIONglobal biopharmaceutical leader
100+countries of operation
~20 NEWproduct launches expected by 2020
$6.2B
+10% cc
$6.2B
+10% cc
$2,840
HEMOPHILIA
$787
INHIBITOR THERAPIES
$1,750
IMMUNOGLOBULIN
THERAPIES
$766
BIOTHERAPEUTICS
$87
ONCOLOGY
$3,315
U.S.
$2,915
INTERNATIONAL
*Growth compares to 2014 pro forma sales; 1H 2015 results include pro forma adjustments
*Growth is at constant currency and compares to 2014 pro forma sales; 1H 2015 results include pro forma adjustments
FY 2015 ACTUAL RESULTS*
EXCEEDING SALES EXPECTATIONS ACROSS ALL PRODUCT CATEGORIES
Hemophilia +4%
Inhibitor Therapies +16%
Hematology +7%
Immunoglobulin Therapies +9%
BioTherapeutics +16%
Immunology +11%
Oncology $87M
Baxalta +10%
(in millions) (in millions)
10 | Baxalta
13. HEMATOLOGY IMMUNOLOGY ONCOLOGY
GENERATING POSITIVE MOMENTUM ACROSS PORTFOLIO*
+7%
FY 2015
+11%
FY 2015
$87M
FY 2015
*Growth is at constant currency and compares to 2014 pro forma sales; 1H 2015 includes pro forma adjustments
*Reflects information as of April 2016. Key Programs = programs with $200M+ peak sales potential
Sales growth measures are presented throughout this annual report on a constant currency and pro forma basis. Sales figures are presented on a pro forma basis.
Please see the company’s website for financial schedules presenting sales growth at actual currency rates and reconciliations from GAAP to pro forma sales.
BUILDING A ROBUST AND DIVERSE PIPELINE: KEY PROGRAMS*
PRE-
CLINICAL
PHASE
II
REG.
REVIEW
PHASE
I
APPROVED
Japan
• ADYNOVATE:
Hemophilia A
U.S.
• ADYNOVATE:
Hemophilia A
• VONVENDI
EU
• OBIZUR: Acquired
Hemophilia A
EU
• ONCASPAR
EU
• ADYNOVI:
Hemophilia A
U.S.
• ADYNOVATE:
Pediatric/Surgery
U.S. EU
• 20% IGSC: PI
EU
• ONIVYDE: 2nd Line
Pancreatic Cancer
Canada
• ONCASPAR
PHASE
III
EU
• VONVENDI (BAX 111)
• HYQVIA: CIDP
Confirmatory
• Etanercept
(BAX 2200)
• Adalimumab
(BAX 923)
• Calaspargase pegol
• ONIVYDE: Gastric
1st Line
• FVIII Gene Therapy
(BAX 888)
• Anti-TFPI: Hemophilia
• Anti-FcƴRIIb (SM2X1):
Myasthenia Gravis
• Anti-FcƴRIIb (SM301):
Allergic Asthma
• EHL rFVIII PSA
(BAX 826)
• rADAMTS13
(BAX 930)
• FIX Gene Therapy
(BAX 335)
• Alpha-1: GvHD
• FcƴRIIb (SM101): SLE
• ONIVYDE: Pancreatic
1st Line
• Imalumab (BAX 069):
Colorectal
• Imalumab (BAX 069):
Malignant Ascites
HEMATOLOGY
IMMUNOLOGY
ONCOLOGY
2015 Annual Report | 11
14. BOARD OF DIRECTORS
EXECUTIVE OFFICERS
Wayne T. Hockmeyer, Ph.D.
Chairman of the Board
Blake E. Devitt
Director
Karen Ferrante, M.D.
Director
from left to right
John D. Forsyth
Director
Gail D. Fosler
Director
James R. Gavin III, M.D., Ph.D.
Director
Ludwig N. Hantson, Ph.D.
Director, Chief Executive Officer and President
François Nader, M.D.
Director
Albert P.L. Stroucken
Director
Dagmar Rosa-Björkeson
Executive Vice President and President, Biosimilars
Peter G. Edwards
Executive Vice President and General Counsel
John Glasspool
Executive Vice President and Head of Corporate Strategy
and Customer Operations
Robert J. Hombach
Executive Vice President, Chief Financial Officer and
Chief Operations Officer
Brian Goff
Executive Vice President and President, Hematology
Anne-Marie Law
Executive Vice President and Head of Human Resources
Jacopo Leonardi
Executive Vice President and President, Immunology
David D. Meek
Executive Vice President and President, Oncology
John J. Orloff, M.D.
Executive Vice President, Head of Research and
Development and Chief Scientific Officer
Ludwig N. Hantson, Ph.D.
Chief Executive Officer and President
Patrice Zagame, M.D.
Executive Vice President and President, Intercontinental
CORPORATE OFFICERS
Eric W. Foster
Senior Vice President and Chief Information Officer
John Furey
Senior Vice President and Head of Global Operations
Mary Kay Ladone
Senior Vice President and Head of Investor Relations
John A. McCoy
Senior Vice President and Controller
Stephanie D. Miller
Senior Vice President, Associate General Counsel
and Corporate Secretary
Todd S. Young
Senior Vice President and Treasurer
12 | Baxalta
15. Transfer Agent and Registrar
Baxaltashareholdersofrecordmaydirectquestionsconcerningstock
accounts, transfers, lost or missing certificates, dividend checks
orotherservicematterstoBaxalta’stransferagent,Computershare.
Internet Access
View account balances and values, purchase and sell shares,
review or change your dividend options, request shareholder
materials, print forms, make address changes or send email
through Computershare’s website (password required for account
access): www.computershare.com/investor.
Telephone Services
Representatives are available weekdays 9:00a.m.–5:00p.m. (ET)
and an automated voice response system is available 24 hours a
day: (866) 433-8297.
Mailing Address
Shareholder correspondence should be mailed to:
Computershare
P.O. Box 30170
College Station, TX 77842-3170
Investor Relations
Analysts, portfolio managers and current and prospective
shareholders seeking additional investor information can contact
the Baxalta Incorporated Investor Relations Department.
CORPORATE INFORMATION
Corporate Headquarters
Baxalta Incorporated
1200 Lakeside Drive
Bannockburn, IL 60015
Mailing Address
Baxalta Incorporated
Investor Relations Department
1200 Lakeside Drive, Mailstop 3NE
Bannockburn, IL 60015
Investor Relations
Mary Kay Ladone
(224) 940-3371
Lorna Williams
(224) 940-3511
Corporate Communications
Geoffrey Mogilner
(224) 940-8619
Design:Edelman,Chicago
16. Baxalta Incorporated
1200 Lakeside Drive
Bannockburn, IL 60015
baxalta.com
Serving patients is our inspiration and we are passionate about improving their lives.
No matter what we do or where we work, we all strive for excellence on behalf of patients,
caregivers and healthcare providers. We seek to understand their journey. Through our
insights, we will deliver breakthrough therapies and personalized services.
We see a world with endless possibilities, where our imagination is inspired and harnessed
with purpose. We embrace the bold and diverse ideas of one another and the world around
us. We build and empower agile, high-performing teams where we can be ourselves.
We hold ourselves and each other accountable to the highest standards of ethics,
integrity and performance. We take the time to celebrate success.
This is how we serve, with our hearts and our heads. This is how we make a meaningful
difference so that our patients can dream big and experience life to the fullest. At Baxalta,
your life is our inspiration.
Our Promise